CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER L—REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION (parts 1210 to 1272) > PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS > SUBPART C—Donor Eligibility (§1271.45 to §1271.90) > 1271.50—How do I determine whether a donor is eligible?

1271.50—How do I determine whether a donor is eligible?

(a) Determination based on screening and testing. If you are the establishment responsible for making the donor-eligibility determination, you must determine whether a donor is eligible based upon the results of donor screening in accordance with § 1271.75 and donor testing in accordance with §§ 1271.80 and 1271.85. A responsible person, as defined in § 1271.3(t), must determine and document the eligibility of a cell or tissue donor.
(b) Eligible donor. A donor is eligible under these provisions only if:
(1) Donor screening in accordance with § 1271.75 indicates that the donor:
(i) Is free from risk factors for, and clinical evidence of, infection due to relevant communicable disease agents and diseases; and
(ii) Is free from communicable disease risks associated with xenotransplantation; and
(2) The results of donor testing for relevant communicable disease agents in accordance with §§ 1271.80 and 1271.85 are negative or nonreactive, except as provided in § 1271.80(d)(1).